Neoplasms

Digestive System Diseases

All Conditions

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Nitrous Oxide

Cryoablation treatment of patients with previously untreated (treatment naïve) Barrett's epithelium.

CryoBalloon Ablation System, a balloon-based cryotherapy device, provides controlled ablation for the treatment of BE. Deployed through the working channel of an endoscope, the Balloon is simultaneously inflated and cooled with an inert cryogen (nitrous oxide) delivered from the handle that ablates the BE cells upon contact with the esophagus.

CryoBalloon Ablation System

Marcia Canto, MD

To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)

Coldplay III is a multi-center, prospective study that will provide evidence of the efficacy and safety of the System in treatment of patients with previously untreated (treatment naïve) low grade dysplasia (LGD) or high grade dysplasia (HGD) BE. Subjects may have a maximum of five (5) ablation treatment sessions during their 12 months of study participation to achieve complete eradication of their dysplastic BE and intestinal metaplasia. As many ablations as needed to treat the dysplastic areas are allowed in each treatment session at the discretion of the investigator.

Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System

Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium

Individual participant data will not be shared.

For Baseline LGD and HGD subjects: progression of dysplasia

(scored on a 0-10 visual analog pain scale)

Pentax Medical

Rare Diseases

Esophageal Neoplasms

Esophageal Cancer

To evaluate safety and treatment effect of the CryoBalloon Ablation System for the Ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy

Tissue Ablation using CryoBalloon Ablation System

Jacques J.G.H.M. Bergman, MD, PhD

To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy

The primary outcomes for the study are the safety and treatment effect of the CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed to determine the treatment effect.

Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy

Clinical Study to Evaluate the CryoBalloon™ Full Ablation System for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy

Incidence of device related serious adverse events

Ease of deployment of the CryoBalloon, procedure time, endoscope compatibility, device malfunction.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System	NCT02514525	Barrett Esophag...	CryoBalloon Abl...	18 Years -	Pentax Medical
Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy	NCT02729727	Esophageal Canc...	CryoBalloon Abl...	18 Years -	Pentax Medical
Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy	NCT02729727	Esophageal Canc...	CryoBalloon Abl...	18 Years -	Pentax Medical

Spots Global Cancer Trial Database for cryoballoon ablation system